Obs study liver transplanted patients given Zutectra &/or Hepatect CP

• Research type

  Research Study

• Full title

  A retrospective data collection to increase the knowledge base of posttransplant treatment with the human hepatitis B immunoglobulin Zutectra or Hepatect CP in liver transplanted patients

• IRAS ID

  169588

• Contact name

  William Gelson

• Sponsor organisation

  Biotest AG

• Duration of Study in the UK

  1 years, 3 months, 12 days

• Research summary

  This is a non-interventional, uncontrolled, single-arm, international, multi-centre, post-approval, retrospective data collection study. The aim of this study is to increase the knowledge base of post-transplant treatment with the human hepatitis B immunoglobulin Zutectra® or Hepatect® CP in liver transplanted patients by evaluating the rate of HBV re-infections after liver transplantation and to gather information about the tolerability of these medications

  The study will involve a retrospective medical records review of approximately 400 adult patients who underwent a liver transplant from the year 2000 because of liver damage or liver cancer caused by an HBV infection and were treated with Hepatect® CP and/or Zutectra® one to ten years after their liver transplantation.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  14/EE/1292

• Date of REC Opinion

  2 Feb 2015

• REC opinion

  Further Information Favourable Opinion